[Federal Register Volume 62, Number 36 (Monday, February 24, 1997)]
[Notices]
[Pages 8242-8244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4621]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00470; FRL-5591-6]
Plant Pesticides Resistance Management; Notice of Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Meeting.
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SUMMARY: EPA will hold a public meeting on March 21, 1997, to solicit
public comment on resistance management plans for plant pesticides,
including the necessity for such plans, critical elements of resistance
management plans and requirements for successful implementation.
DATES: The meeting will be held on March 21, 1997, from 8:30 am until 5
pm. Written comments from interested parties not able to attend the
meeting must be received on or before March 21, 1997. Persons who wish
to speak at the public meeting are encouraged to register in advance by
submitting a brief written request and abstract to EPA on or before
March 14, 1997.
ADDRESSES: The meeting is open to the public and will be held in the
EPA Auditorium at EPA Headquarters, 401 M St., SW., Washington, DC
20460. Interested parties who cannot attend the public meeting but who
wish to comment may do so by submitting written comments. Comments
should be identified by the docket control number OPP-00470, and be
submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket control number OPP-00470. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments may be
filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found in Unit IV of this
document.
FOR FURTHER INFORMATION CONTACT: By mail: Willie H. Nelson,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, U. S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460. Office location, telephone number and e-mail
address: 5th Floor CS, 2800 Crystal Drive, Arlington, VA 22202,
Telephone No: 703-308-8682, e-mail:nelson.willie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Resistance management has been a consideration for the registration
of plant pesticides for some time. This is because plant pesticides
tend to produce the pesticidal active ingredient throughout a growing
season, increasing the selection pressure upon both the target pests
and any other susceptible insects feeding on the transformed crop.
Resistance management has become an issue particularly in relation
to plant-pesticides based on the insecticidal proteins from the
bacterium Bacillus thuringiensis (Bt). EPA recognizes the value of Bt
as a safer pesticide and has determined that it is necessary to
conserve this resource as appropriate by requiring resistance
management plans. The Agency has reviewed initial strategies from
registrants for managing resistance to Bt delta endotoxins produced in
potato, corn, and cotton. EPA has worked with stakeholders (industry,
public sector research and extension, growers, user groups, and
government agencies) to address resistance management for primarily Bt-
based plant pesticides.
In March of 1995, EPA held a Scientific Advisory Panel (SAP)
meeting as part of the review for the first registered plant
pesticides. This meeting primarily addressed issues related to the
Bacillus thuringiensis (Bt) tenebrionis CryIII delta endotoxin in
potato, although some issues related to Bt corn and Bt cotton were also
discussed. The
[[Page 8243]]
Panel stated in their review that the submitted resistance management
plan (RMP) is a ``scientifically credible Colorado potato beetle (CPB)
resistance management protocol.'' For the Bt potato, the SAP
recommended that the applicant should have specific monitoring plans
for resistance which should be sent to the Agency for review. The SAP
also requested that the applicant make specific recommendations on what
course of action should be taken if resistance should be discovered. It
was the opinion of the panel that EPA should work with the applicant in
developing a long-term RMP, but that such plans should not be a formal
condition of registration. EPA agreed with this assessment for Bt
potato as the pesticide was only for the control of the Colorado Potato
Beetle, the CryIII delta endotoxin was at a high dose, and existing Bt
tenebrionis sprayable products only worked for early instars of this
pest. In addition, the Colorado potato beetle has a limited host range
of economic crops.
The SAP further agreed with the seven elements, described by OPP,
that need to be addressed to develop an adequate resistance management
plan for plant-pesticides. These elements are: (1) Knowledge of pest
biology and ecology, (2) Appropriate gene deployment strategy, (3)
Appropriate refugia (primarily for insecticides, (4) Monitoring and
reporting of incidents of pesticide resistance development, (5)
Employment of Integrated pest management (IPM), (6) Communication and
educational strategies for use of the product and (7) Development of
alternative modes of action.
Bt CryIA(b) delta endotoxin in corn was the second plant pesticide
registered. This product was intended primarily for the control of the
European corn borer. EPA noted in its review of the application that
other lepidopterous pests that also feed on corn might be affected by
the endotoxin, and therefore have the potential for the development of
resistance to Bt. This review also noted that both the primary pests
claimed on the label and those secondary pests may be controlled by the
use of existing sprayable Bt products. Bt is considered to be a reduced
risk pesticide and corn is planted in large acreages in the United
States. Therefore the Agency required the development of a resistance
management plan as a condition of the corn Bt registrations, so that
such plans could be implemented if pest resistance was detected.
Bt cotton containing CryIA(c) was the last plant pesticide crop to
be registered. For Bt cotton, there was compelling evidence to require
the implementation of a RMP as a condition of the registration. This
was due to the fact that: (1) Bt was already used extensively on
cotton, (2) corn earworm (a primary pest, known as the bollworm when
feeding on cotton) moves from corn to cotton thus extending the period
of exposure to the Bt toxin, and (3) that corn earworm feeds on many
other crops that are treated with Bt in significant amounts. Cotton is
also planted in large acreages in the United States. An RMP was
therefore required as a condition of the registration for Bt Cotton.
The Pesticide Program Dialogue Committee (PPDC) is a group
representing various interests and points of view including public
interest, industry, users, public health, legal, Congress, and the
general public. The PPDC meeting in July of 1996 addressed the issue of
resistance management. OPP asked the committee for their views on the
best approach for the Agency to take in addressing the problem of pest
resistance; the need for a new active ingredient screening process;
whether OPP should address the problem of pest resistance to already
registered pesticides; and whether resistance management
recommendations should be required on pesticide labeling.
Panelists agreed that EPA should have some role in resistance
management, but disagreed as to what that role should be. Panelists
indicated that EPA should not make resistance management mandatory in
all cases.
It was the general opinion of the PPDC that the Agency should
function as a liaison or clearing house for RMP information, but only
require resistance management plans as part of the registration when
the development of resistance would cause the potential loss of a
pesticide that was in the ``public good'', like Bt. The committee found
it difficult to define ``public good'' parameters. Other panelists
commented that EPA needed to provide more alternative tools for minor
crops, and one panelist suggested that EPA could promote better
resistance management by classifying pesticides according to their mode
of action similar to Canadian requirements.
During the 1996 season, there were numerous instances reported to
EPA where Bt cotton failed to control a segment of the bollworm
population. The registrant has submitted a report concerning these
instances. The report is currently under review by the Agency to
determine how pest populations, and crop performance is related to
resistance management.
II. Information Sought by EPA
EPA is required by law to ensure that pesticides have a reasonable
certainty of no harm to people (including infants and children) and do
not cause unreasonable adverse effects to the environment. As part of
the evaluation process, the Agency collects information on the risks
and benefits of pesticides. The Agency is interested in soliciting
public comment regarding resistance management plans for plant
pesticides because resistance management plans are a new requirement
related to a novel technology.
1. The requirement for resistance management plans. This will
include information on the criteria for requiring a resistance
management plan and whether such plans should be voluntary or mandatory
(conditions of registration).
2. Scientific needs for resistance management plans. Certain data
may be required in order to adequately evaluate resistance management
plans. EPA needs information on what kinds of data should be required
to assess the potential for resistance and/or adequately evaluate
proposed plans.
3. ``Public good'' criteria. The Agency wants comment on whether
this criteria should be used, and if so, information on the definition
or determination of when a pesticide would be in the ``public good.''
4. Performance failures for Bt cotton. Information concerning the
control failures for Bt cotton, suggested evaluation tools concerning
these failures, and implications on future resistance management
efforts.
III. Registration For Purposes of Commenting
Persons who wish to speak at the public meeting are encouraged to
register in advance by submitting a brief written request to EPA on or
before March 14, 1997. Those who do not register by March 14 may
register in person, on March 21, to make a presentation if time
permits. Register by mail with the person listed under FOR FURTHER
INFORMATION CONTACT.
IV. Public Record
The Agency encourages parties to submit data to substantiate
comments whenever possible. A record has been established for this
rulemaking under docket control number OPP-00470 (including comments
and data submitted electronically as described below). A public version
of this record, including printed, paper versions of electronic
comments, which does not include any information claimed as CBI,
[[Page 8244]]
is available for inspection from 8:30 am to 4 pm, Monday through
Friday, excluding legal holidays. The public record is located in Room
1132 of the Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia address in ``ADDRESSES'' at the
beginning of this document.
Information submitted as part of any comment may be claimed as
confidential by marking any or all of that information as Confidential
Business Information (CBI). Information so marked will not be disclosed
except in accordance with the procedures set forth in 40 CFR part 2. A
copy of the comment that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by the Agency without prior notice. The Agency
anticipates that most of the comments will not be classified as CBI,
and prefers that all information submitted be publicly available. Any
records or transcripts of the open meeting will be considered public
information and cannot be declared CBI.
V. Structure of the Meeting
EPA will open the meeting with brief introductory comments. EPA
will then invite those parties who have registered by March 14 to
present their comments. Those who register the day of the meeting will
be offered the opportunity to present their comments if time permits.
EPA anticipates that each speaker will be permitted about 10 minutes to
make comments. After each speaker, Agency representatives may ask the
presenter questions of clarification. The Agency reserves the right to
adjust the time for presenters depending upon the number of speakers.
Members of the public are encouraged to submit written
documentation to EPA at the meeting to ensure that their entire
position goes on record in the event that time does not permit a
complete oral presentation. Written comments should include the name
and address of the author as well as any sources used. Written
documentation should be submitted to Willie H. Nelson at the address
stated earlier in this notice.
Dated: February 19, 1997.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 97-4621 Filed 2-20-97; 1:07 pm]
BILLING CODE 6560-50-F
